BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20093245 · Received August 29, 2024

    Report

    Report Number
    2955842-2024-18687
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS RECEIVED THE USM EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE UNIT CAME IN FOR ERROR 32097 AC_3D. IT WAS CONFIRMED AND REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED NO ERRORS. THE UNIT WAS ALSO TESTED ON THE PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND FAILED FIBER TESTS. A GOLD PARALLELOGRAM WAS INSTALLED, AND THE UNIT PASSED. THE ORIGINAL WAS RETURNED, AND THE UNIT FAILED. UPON FURTHER INVESTIGATION, THERE WAS NO FLUID INTRUSION OR PHYSICAL DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLOSTOMY CLOSURE SURGICAL PROCEDURE, THE SITE EXPERIENCED FAULTS ON ARM 3. THE CUSTOMER POWER CYCLED THE SYSTEM BETWEEN PROCEDURES. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR 32097 AGAINST ARM 3. THE TSE INFORMED THE CALLER THAT THE ERROR WAS RELATED TO A HARDWARE ISSUE AND LIKELY TO RETURN. THE SITE CONTINUED WITH THE PROCEDURE AND ADVISED THEY WOULD BE TAKING THE SYSTEM DOWN AFTER THE PROCEDURE. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180372 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES